A Study of ARRY-334543 and Docetaxel in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in this study.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; Drug: Docetaxel, mitotic inhibitor; intravenous; Drug: Prophylactic growth factors; subcutaneous

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel.
• Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
• Must be able to take and retain oral medications.
• Other criteria exist.

Key Exclusion Criteria:

• Active concomitant malignancies.
• Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start).
• Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
• Requiring intravenous (IV) alimentation.
• Pregnancy or lactation.
• Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
• Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.
• History of hypersensitivity to or intolerance of docetaxel.
• Other criteria exist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARRY-334543 + docetaxel + prophylactic growth factors	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; multiple dose, escalating; Drug: Docetaxel, mitotic inhibitor; intravenous; multiple dose, single schedule; Drug: Prophylactic growth factors; subcutaneous; standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish the maximum tolerated dose (MTD) of study drug in combination with docetaxel.	Duration of study
Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms.	Duration of study
Characterize the pharmacokinetics (PK) of study drug and docetaxel.	Duration of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response.	Duration of study

Collaborators and Investigators

• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 2, 2009

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Mitosis Modulators; Docetaxel; Mitogens; Antimitotic Agents
• Other Study ID Numbers: ARRAY-543-104